In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
PegIntron 0.5 mcg/kg SC QW for 12 weeks
PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks
Percentage of patients who achieve normalization of ALT in each treatment group
Time frame: Measured at the end of 12 weeks of treatment or at discontinuation.
Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test)
Time frame: Measured between when the patient signs the informed consent form and the end of post-treatment follow-up
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